11 results
·
23ms
·
Sources: EU EUDAMED, US FDA
BBL DIRECTIGEN TEST KIT
FDA 510(k)
FDA Class 1
·Microbiology
ERA® Implant Abutment Micro Ang. Base, 4mm Cuff (K)
FDA UDI
STERNGOLD DENTAL LLC·00841549104800·Implant retained overdentures are an establishe...
Aspida® Anterior Lumbar Plating System
FDA 510(k)
FDA Class 2
·Orthopedic
OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR COCAINE AND COCAINE METABOLITES
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·December 8, 2025
ELECSYS HBSAG II
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LOM·September 17, 2025
REALSEAL
FDA Adverse Event
Injury
·SYBRONENDO·Product code KIF·May 15, 2014
PARADIGM INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LZG·October 31, 2012
PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·August 24, 2010
COBAS 6000 E601 MODULE
FDA Adverse Event
Injury
·ROCHE DIAGNOSTICS·Product code JJE·August 13, 2025
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023